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NCT01200758COMPLETEDanonymous

A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV

Sponsor

Source record

Hoffmann-La Roche

Phase

Source record

PHASE3

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone

Indication / condition

AI-normalized

Non-Hodgkin's Lymphoma

Intervention

Source record

Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone

Source & freshness

Source record

NCT ID

NCT01200758

Original source

ClinicalTrials.gov

Source last updated

Nov 27, 2018

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01200758

Title

A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV

Sponsor

Hoffmann-La Roche

Status

COMPLETED

Phase

PHASE3

Condition raw

Non-Hodgkin's Lymphoma

Condition normalized

Non-Hodgkin's Lymphoma

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone

Target normalized

Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone

Interventions

Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone

Public preview

Source record

This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m\^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.

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